Impact of Patient-Reported Outcomes for Symptom Monitoring in Patients Followed for Head and Neck Squamous Cell Carcinoma (HNSCC)

Not Applicable

Not yet recruiting

• Conditions: Head and Neck Squamous Cell Carcinoma HNSCC

• Registration Number: NCT07190755
• Lead Sponsor: Centre Henri Becquerel

Brief Summary

The use of digital strategies to systematically monitor patients' symptoms in clinical settings allows problems to be detected at an early stage before they worsen or lead to complications. In this study, the hypothesis is that the proportion of patients with a weight loss of at least 5% between before radiotherapy/radiochemotherapy and 3 months after treatment would be lower with optimised care thanks to remote monitoring using a medical telemonitoring solution in oncology.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-09
• Study First Submitted: 2025-09-17
• Study First Submitted QC: 2025-09-17
• Last Update Submitted: 2025-09-17
• Study First Posted: 2025-09-24
• Last Update Posted: 2025-09-24
• Study Start: 2025-10-01
• Primary Completion: 2030-06-01
• Study Completion: 2030-06-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 192

Inclusion Criteria

• Patient aged over 18 and under 75 years WHO score < 2,

  • Treated for localised heand and neck cancer of the squamous cell carcinoma type for which curative treatment has been chosen and receiving radiotherapy or radio-chemotherapy exclusively or as an adjuvant with the aim of cure
  • Having signed the informed consent form,
  • Affiliated with or beneficiary of a social protection scheme,
  • Access to a smartphone or the internet,

Exclusion Criteria

• History of other neoplastic disease less than 2 years ago or progressive disease,
• History of ENT radiotherapy,
• Pregnant or breastfeeding women,
• Protected adults (under guardianship, curatorship or judicial protection),
• Patients participating in a therapeutic study,
• Patients unable to understand the study for any reason or to comply with the constraints of the trial (language, psychological or geographical issues, etc.), patients with blindness preventing the use of the medical telemonitoring solution in oncology.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Impact of remote monitoring of symptoms on weight loss	3 months after treatment	Proportion of patients with at least a 5% reduction in weight 3 months after treatment compared to the consultation at the start of radiotherapy or radiochemotherapy

Secondary Outcome Measures

Name	Time	Method
Impact of remote symptoms monitoring on global survival	18 month after treatment	Time beetween inclusion and death for any cause

Trial Locations

Locations (2)

Centre Henri Becquerel; 🇫🇷 Rouen, France

Institut de Cancérologie de Lorraine; 🇫🇷 Vandœuvre-lès-Nancy, France